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临床试验/NCT03308058
NCT03308058已完成不适用

Feasibility of a Touch Screen Computer Based Breast-feeding Educational Support Program

University of Nebraska1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2012年10月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Breastfeeding Assessment

研究概览

简要总结

Breastfeeding has many positive and long lasting impacts on the health of infants and mothers. The investigators propose to develop a bilingual touch screen computer based breastfeeding educational support program to promote breastfeeding among Hispanic rural women living in Scottsbluff area of rural Nebraska. An interactive, tailored, touch screen, bilingual breastfeeding educational program will be developed to deliver breastfeeding education to enhance partial or exclusive breastfeeding. An experimental two-group repeated measures design will be utilized. Ninety four prenatal Hispanic rural women aged 15 years and above will be enrolled and randomly assigned to either the intervention (computer based program, N=47) or attention control (printed educational material, N=47) groups at the Regional West Medical Center in Scottsbluff. Information gathered will include socio-demographics, familiarity with use of technology and health literacy assessment. Process variables measured will include breast-feeding knowledge and breast-feeding self-efficacy. Primary and secondary outcomes include breast-feeding duration in binary categories (partial or exclusive) and number of sick baby medical visits and months of illnesses. All assessments will be done at baseline, days 3 and 7, weeks 2 and 6 and months 3 and 6 in both the intervention and attention intervention groups. The current proposed study may help advance our understanding to use health information technology as a medium to disseminate bilingual health education programs in rural settings. This exploratory study will lay a foundation for a larger multicenter randomized controlled clinical trial to evaluate the impact of computer based educational intervention to promote sustainability of breastfeeding among women across diverse settings.

详细描述

Two separate focus groups one in English and Spanish will be performed with six Hispanic rural women with history of previous pregnancy will be enrolled at the Regional West Medical Center (RWMC), Scottsbluff, NE. The focus group of 2 hours duration will be performed at the antenatal clinic at RWMC during months 2 and 3 of the study. The focus group will help examine factors that affect the decision to continue breast-feeding in pregnant Hispanic rural women and will guide development of bilingual (English and Spanish) breast-feeding educational modules during months 4 and 5 of the study. Dr. Aguirre and Ms. Salazar will be responsible for subject recruitment, focus group assessments and would act as a moderator and respond to questions and comments during the focus groups. The focus group interviews, analysis and development of breast-feeding educational modules in English and Spanish will be finalized during the first 5 months of the study. The focus group sessions will be audio recorded and stored in a locked cabinet. The sessions recordings will be destroyed at the end of the research study.

Computer-based Breast-Feeding Educational Support Program: The investigators will modify existing touch screen, computer based interactive Patient Education and Motivation Tool (PEMT) to deliver bilingual, breast-feeding educational support program. The existing PEMT platform allows users to dynamically change the educational content either to English or Spanish. The modification of the existing PEMT will occur during months 5-7 and will include several stages:

(i) PEMT modification design (ii) Tailoring (iii) Expert Pretesting using Heuristic evaluation (iv) Usability and User Testing

Intervention and Evaluation:

The subjects will be randomly enrolled using a 1:1 method with every other subject enrolled randomized to either the control or intervention group, at RWMC, Scottsbluff. Eligible individuals, who will meet the inclusion criteria, will be assigned into either intervention (bilingual Computer based Breast-feeding Educational Support program) or attention control (bilingual breast-feeding printed educational material) groups using a computer generated random id during the subject's prenatal visit (i.e. anytime during last six weeks of their pregnancy). Once randomized, baseline information will be gathered in both the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 35 Years(Child, Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Hispanic females age 15 years and above
  • •Agreeing to participate in the study
  • •Understand spoken English
  • •Telephone at home
  • •Available for follow-up interview.

排除标准

  • •mental and physical challenge that makes it difficult to use the touch based computer program
  • •unavailability for telephone follow-up and
  • •involvement in other clinical trials or protocols related to breastfeeding.

研究组 & 干预措施

Breastfeeding Computer education

Experimental

Breastfeeding Computer education

干预措施: Breastfeeding computer education (Behavioral)

Printed Educational material

No Intervention

Printed educational material

结局指标

主要结局

Breastfeeding Assessment

时间窗: 0-6 months

Questionnaire Breastfeeding duration (Specify time) __________

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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